Assured Pregnancy Test sensitivity 2019

Assured Pregnancy Test sensitivity 2018

Assured Pregnancy Test sensitivity 2019 hasn’t changed since the U.S. Food and Drug Administration first approved the product in 2011.

The test is able to detect pregnancy 11 days after ovulation, for most women.

For practical purposes, the Assured Pregnancy Test is 99% accurate on the first day of your expected menstrual period.

Assured Pregnancy Test sensitivity 2019

The official rating for Assured Pregnancy Test sensitivity 2019 is 25 mIU/ml (Milli-International Units of HCG hormone per milliliter of urine).

What is HCG?

HCG stands for human chorionic gonadotropin. Commonly known as “the pregnancy hormone,” it’s a key indicator for pregnancy.

How does the Assured Pregnancy Test detect HCG?

A test strip that is sensitive to HCG is inside your Assured Pregnancy Test cassette. When you have an HCG concentration of 25 ml or more in your urine, the test will show a line in both the “Control” and “Test” areas of the device.

Here’s how the manufacturer describes the test to the FDA:

Presence of the red band in the test region indicates a positive result, while its absence indicates a negative result. Regardless of the presence of hCG, a red band at the control band region will always appear.

https://www.accessdata.fda.gov/cdrh_docs/reviews/K123703.pdf

Can I test early with Assured Pregnancy Test?

No. The Assured Pregnancy Test is not an early result Pregnancy Test. The test does not reliably provide results for HCG concentrations below 25 mIU/ml.

How does the Assured Pregnancy Test Sensitivity compare with FRER Digital?

In our article about FRER Digital Sensitivity, we reported that product has a sensitivity rating of 10 mIU/ml. The FRER test has a 50% accuracy rate at 6 mIU/ml, making it suitable for use as an early result test.

Can I get more information from the FDA?

Yes. The device approved by the FDA for Healgen was previously approved.

Read FDA document K103574 to get more information.

In this document, a different manufacturer, Zhejiang Orient Gene Biotech, Co., Ltd, submitted the identical product to the FDA.

What’s the difference between FDA K103574 and K123703?

The device sold as the Assured Pregnancy Test was first approved by the FDA (K103574) “for professional use only.” In document K123703, the FDA approves the device for OTC sales.

Don’t leave without learning more!

In this article, you’ve learned that Assured Pregnancy Test Sensitivity 2019 is 25 mIU/ml. That specification hasn’t changed in almost a decade.

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